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Real-world safety profile of lecanemab: A disproportionality analysis of adverse events in the FDA adverse event reporting system
Jayoung Han, Yuan Fang, Nicole Campbell. JAPhA Pharmacotherapy, 2025-04-01
Topic: Risk, prevention and care in population studies
Background Lecanemab, an antiamyloid monoclonal antibody, has emerged as a treatment option for Alzheimer disease. However, there is a pressing need for real-world evidence to inform clinical practice, particularly regarding its safety profile. Objectives This study aimed to analyze adverse events (AEs) associated with lecanemab using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods All cases reporting AEs were included if reported during the study period, from January 1, 2023, to June 30, 2024, during which a total of 1,307,937 cases were reported in the FAERS database. A disproportionality analysis was conducted to assess adverse reactions associated with lecanemab. Reporting odds ratios (RORs) with 95% CIs were extracted from OpenVigil 2.1-MedDRA-v24 for lecanemab-related events. Results The analysis identified a total of 1679 AEs associated with lecanemab during the study period. The strongest safety signal was observed for amyloid-related imaging abnormalities (ARIAs), particularly ARIA with hemosiderin deposits in the brain parenchyma or on the pial surface (microhemorrhages, ROR 11,221.5 [95% CI 5706.2–22,067.5]) and ARIA with brain edema or sulcal effusion (edema/effusion, ROR 8927.3 [95% CI 5243.6–15,199.1]). Other notable AEs included infusion-related reactions (ROR 24.9 [95% CI 18.9–32.8]), headache (ROR 10.2 [95% CI 8.6–12.2]), and confusional states (ROR 15.0 [95% CI 11.4–19.7]). Conclusion This study underscores the importance of vigilant monitoring for ARIA and other neurologic and psychiatric AEs associated with lecanemab in real-world clinical settings. The findings highlight the need for ongoing postmarket surveillance to ensure patient safety and guide clinical decision making.
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APA 7th
Han, J., Fang, Y., & Campbell, N. (2025). Real-world safety profile of lecanemab: A disproportionality analysis of adverse events in the FDA adverse event reporting system. JAPhA Pharmacotherapy. https://doi.org/10.1016/j.japhar.2025.100015
Vancouver
Han J, Fang Y, Campbell N. Real-world safety profile of lecanemab: A disproportionality analysis of adverse events in the FDA adverse event reporting system. JAPhA Pharmacotherapy. 2025. doi:10.1016/j.japhar.2025.100015.
BibTeX
@article{han2025-cbaaba6e,
author = {Han, Jayoung and Fang, Yuan and Campbell, Nicole},
title = {{Real-world safety profile of lecanemab: A disproportionality analysis of adverse events in the FDA adverse event reporting system}},
journal = {JAPhA Pharmacotherapy},
year = {2025},
doi = {10.1016/j.japhar.2025.100015},
url = {https://doi.org/10.1016/j.japhar.2025.100015}
}
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Key findings
- Objectives This study aimed to analyze adverse events (AEs) associated with lecanemab using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
- A disproportionality analysis was conducted to assess adverse reactions associated with lecanemab.
- Results The analysis identified a total of 1679 AEs associated with lecanemab during the study period.
- Conclusion This study underscores the importance of vigilant monitoring for ARIA and other neurologic and psychiatric AEs associated with lecanemab in real-world clinical settings.
Why it matters
In an analysis of FDA adverse event reports, the strongest safety signals for lecanemab were amyloid-related imaging abnormalities, including microhemorrhages and brain edema or sulcal effusion, along with infusion-related reactions and headache. The authors stress the importance of vigilant monitoring for ARIA and other neurologic and psychiatric adverse events.
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Study details
- Participants1,307,937
- Effect sizeOR 8927.3; OR 24.9; OR 10.2
- Evidence strengthLow
How this study scored 38/100
Published in a peer-reviewed journal. Scored zero for study design and randomised / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (JAPhA Pharmacotherapy) |
| Journal's citation record | 0 / 4 | JAPhA Pharmacotherapy: journal h-index 2 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 4 / 4 | 1,307,937 participants |
| Effect reported | 3 / 3 | Effect reported with a statistic (interval, p-value, ratio or similar) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 1 / 7 | Cited 1 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.3 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 2 / 6 | Cited 1.4× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 0 / 4 | Cited 1 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 0 / 4 | Last-listed author Nicole Campbell: h-index 3 (OpenAlex, whole career) |
| Institution's track record | 0 / 3 | Fairleigh Dickinson University: institution h-index 177 (OpenAlex) |
| Multi-centre collaboration | 0 / 3 | OpenAlex lists 1 institution(s) in 1 country — scores zero (affiliation lists can be incomplete) |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | 2 / 2 | Free to read |
| Total | 38 / 100 | — |
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